ConstipationHRAMpositionNCT06924957
Influence of Body Position on the Defecation Model During Anorectal Manometry.
An observational study of Constipation and Children, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Children, Anorectal Disorder
- What is being tested?
- 3D HRAM
- Type of treatment
- Injection or infusion
- How many people
- 84 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jan 2020to 17 Aug 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The sample size was calculated to detect a 45% difference in the percentage of patients with a negative rectoanal gradient, assuming equal groups, alpha = 0.05, beta = 0.1, and a 30% drop out percentage. There should be 30 people in the constipation group and 30 healthy volunteers. Due to possible differences depending on age, it was decided to conduct the study in two separate age groups (I. younger, i.e. 5-10 years old and II. older, 11-18 years old). The total number of patients in the study will therefore be 120 people.
Who may be able to join
- age from 5 to 18 years old
- functional constipation diagnosed on the basis of Rome IV criteria
- parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent
- age from 5 to 18 years old
- no lower gastrointestinal symptoms
- parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent
Who cannot join
- undergone surgeries due to congenital anomalies in the lower gastrointestinal tract
- inflammatory bowel diseases or inflammation of the large intestine with a different aetiology
- anal fissure, inflammation of the anal area or other conditions which, in the opinion of the researcher, could affect the functioning of the distal gastrointestinal tract
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Department of Paediatric Gastroenterology and Nutrition, Warsaw Medical University
Warsaw, Masovian Voivodeship, 02-091
About this study
Official title: Influence of Body Position on the Defecation Model Measured During High Resolution Anorectal Manometry in Children- a Control Study.
Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Resent studies suggest that the position in which 3D HRAM is performed should be changed. So far, no scientific research has been performed in children that directly compares both positions. The reference values of registered pressures during 3D HRAM in people without complaints were not specified, which would allow for a more precise diagnosis of patients with an incorrect defecation model and precise selection of patients who could benefit from biofeedback therapy.
Read the detailed description
Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry in both- sitted and lying position.
During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.
- Conditions
- Constipation, Children, Anorectal Disorder
- Being tested
- 3D HRAM
- Keywords
- anorectal manometry, HRAM, constipasion, position
- Medical subject headings
- Constipation, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D HRAMOther
Also called Three-dimensional high-resolution anorectal manometry
The test will be performed both in supine and sitting position successively, using 3D HR-ARM. Resting, squeeze pressures, and bear down manoeuvre variables will be obtained. Diagnosis of dyssynergic defecation requires < 20% relaxation of anal sphincter and/or intrarectal pressure>40 mmHg during bear down manoeuvre.
| Study group | Role | What they receive |
|---|---|---|
| Constipation group | Children that meet Rome IV criteria to diagnose functional constipation. Receives: Other: 3D HRAM | |
| Healthy volounteers | Children without IBD, without chronic diseases of GI tract nor history of anorectal surgery Receives: Other: 3D HRAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
DD frequency
The difference in the number of patients with DD (defined as <20% relaxation of anal sphincter and/or intrarectal pressure >40 mmHg during bear down manoeuvre) in sitting and lying position.
Measured: 1 day
Secondary outcomes (3)
Values of pressures obtained during anorectal manometry
Values of manometric parameters obtained in the lying and sitting position: mean resting pressure of the anal sphincter (mmHg), maximum squeeze pressure (mmHg), residual anal pressure (mmHg).
Measured: 1 day
Values of mean anal canal length
The mean anal canal length will be assessed in sitting and lying position in the two groups.
Measured: 1 day
Percentage of anal relaxation rate
the assessment of parameters of defecation dynamics during HR-ARM: rectoanal pressure gradient. All secondary end points will be assessed in sitting and lying position in the two groups.
the assessment of parameters of defecation dynamics during HR-ARM: percentage of anal relaxation rate, rectoanal pressure gradient. All secondary
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start10 Jan 2020
- Primary completion17 Aug 2026
- Study completion17 Aug 2026
Why it stopped: Low rate of enrolment of patients in control group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Marcin Banasiuk, Medical University of Warsaw
- Investigators
- Barbara Skowrońska, MD, Principal investigator, Department of Pediatric Gastroenterology Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924957
- Sponsor's protocol ID
- Banasiuk2021B
- Acronym
- HRAMposition
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rao SS, Kavlock R, Rao S. Influence of body position and stool characteristics on defecation in humans. Am J Gastroenterol. 2006 Dec;101(12):2790-6. doi: 10.1111/j.1572-0241.2006.00827.x. Epub 2006 Oct 6.
PubMed 17026568Su H, Peng LH, Sun G, Yang YS, Wu J, Jiang GJ, Ge H. Effect of different body position on anorectal manometry for chronic constipation patients. Eur Rev Med Pharmacol Sci. 2019 Oct;23(19):8493-8500. doi: 10.26355/eurrev_201910_19162.
PubMed 31646580Wu GJ, Xu F, Lin L, Pasricha PJ, Chen JDZ. Anorectal manometry: Should it be performed in a seated position? Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12997. Epub 2016 Dec 1.
PubMed 27910245Coss-Adame E, Rao SS, Valestin J, Ali-Azamar A, Remes-Troche JM. Accuracy and Reproducibility of High-definition Anorectal Manometry and Pressure Topography Analyses in Healthy Subjects. Clin Gastroenterol Hepatol. 2015 Jun;13(6):1143-50.e1. doi: 10.1016/j.cgh.2014.12.034. Epub 2015 Jan 20.
PubMed 25616028Grossi U, Carrington EV, Bharucha AE, Horrocks EJ, Scott SM, Knowles CH. Diagnostic accuracy study of anorectal manometry for diagnosis of dyssynergic defecation. Gut. 2016 Mar;65(3):447-55. doi: 10.1136/gutjnl-2014-308835. Epub 2015 Mar 12.
PubMed 25765461Skowronska B, Banaszkiewicz A, Banasiuk M. Influence of body position on defecation mechanics measured during high-resolution anorectal manometry in paediatric population: a protocol for case-control study. BMJ Open. 2025 Dec 31;15(12):e112928. doi: 10.1136/bmjopen-2025-112928.
PubMed 41475818
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Body Position on the Defecation Model Measured During High Resolution Anorectal Manometry in Children- a Control Study.
- ClinicalTrials.gov ID
- NCT06924957
- Acronym / sponsor ID
- HRAMposition / Banasiuk2021B
- Conditions
- Constipation, Children, Anorectal Disorder
- Keywords
- anorectal manometry, HRAM, constipasion, position
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low rate of enrolment of patients in control group
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Resent studies suggest that the position in which 3D HRAM is performed should be changed. So far, no scientific research has been performed in children that directly compares both positions. The reference values of registered pressures during 3D HRAM in people without complaints were not specified, which would allow for a more precise diagnosis of patients with an incorrect defecation model and precise selection of patients who could benefit from biofeedback therapy.
Detailed description
Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry in both- sitted and lying position.
During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constipation group | – | Other: 3D HRAMChildren that meet Rome IV criteria to diagnose functional constipation. |
| Healthy volounteers | – | Other: 3D HRAMChildren without IBD, without chronic diseases of GI tract nor history of anorectal surgery |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The sample size was calculated to detect a 45% difference in the percentage of patients with a negative rectoanal gradient, assuming equal groups, alpha = 0.05, beta = 0.1, and a 30% drop out percentage. There should be 30 people in the constipation group and 30 healthy volunteers. Due to possible differences depending on age, it was decided to conduct the study in two separate age groups (I. younger, i.e. 5-10 years old and II. older, 11-18 years old). The total number of patients in the study will therefore be 120 people.
Key inclusion criteria (6 listed)
- age from 5 to 18 years old
- functional constipation diagnosed on the basis of Rome IV criteria
- parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent
- age from 5 to 18 years old
- no lower gastrointestinal symptoms
Key exclusion criteria (3 listed)
- undergone surgeries due to congenital anomalies in the lower gastrointestinal tract
- inflammatory bowel diseases or inflammation of the large intestine with a different aetiology
- anal fissure, inflammation of the anal area or other conditions which, in the opinion of the researcher, could affect the functioning of the distal gastrointestinal tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D HRAMAlso: Three-dimensional high-resolution anorectal manometryThe test will be performed both in supine and sitting position successively, using 3D HR-ARM. Resting, squeeze pressures, and bear down manoeuvre variables will be obtained. Diagnosis of dyssynergic defecation requires < 20% relaxation of anal sphincter and/or intrarectal pressure>40 mmHg during bear down manoeuvre. | Other | Constipation group, Healthy volounteers |
Primary outcome
DD frequency
Time frame: 1 day
The difference in the number of patients with DD (defined as <20% relaxation of anal sphincter and/or intrarectal pressure >40 mmHg during bear down manoeuvre) in sitting and lying position.
3 secondary outcomes
Values of pressures obtained during anorectal manometry
Time frame: 1 day
Values of mean anal canal length
Time frame: 1 day
Percentage of anal relaxation rate
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Low rate of enrolment of patients in control group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 17026568Rao SS, Kavlock R, Rao S. Influence of body position and stool characteristics on defecation in humans. Am J Gastroenterol. 2006 Dec;101(12):2790-6. doi: 10.1111/j.1572-0241.2006.00827.x. Epub 2006 Oct 6.
- Background: PubMed 31646580Su H, Peng LH, Sun G, Yang YS, Wu J, Jiang GJ, Ge H. Effect of different body position on anorectal manometry for chronic constipation patients. Eur Rev Med Pharmacol Sci. 2019 Oct;23(19):8493-8500. doi: 10.26355/eurrev_201910_19162.
- Background: PubMed 27910245Wu GJ, Xu F, Lin L, Pasricha PJ, Chen JDZ. Anorectal manometry: Should it be performed in a seated position? Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12997. Epub 2016 Dec 1.
- Background: PubMed 25616028Coss-Adame E, Rao SS, Valestin J, Ali-Azamar A, Remes-Troche JM. Accuracy and Reproducibility of High-definition Anorectal Manometry and Pressure Topography Analyses in Healthy Subjects. Clin Gastroenterol Hepatol. 2015 Jun;13(6):1143-50.e1. doi: 10.1016/j.cgh.2014.12.034. Epub 2015 Jan 20.
- Background: PubMed 25765461Grossi U, Carrington EV, Bharucha AE, Horrocks EJ, Scott SM, Knowles CH. Diagnostic accuracy study of anorectal manometry for diagnosis of dyssynergic defecation. Gut. 2016 Mar;65(3):447-55. doi: 10.1136/gutjnl-2014-308835. Epub 2015 Mar 12.
- Derived from this study: PubMed 41475818Skowronska B, Banaszkiewicz A, Banasiuk M. Influence of body position on defecation mechanics measured during high-resolution anorectal manometry in paediatric population: a protocol for case-control study. BMJ Open. 2025 Dec 31;15(12):e112928. doi: 10.1136/bmjopen-2025-112928.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Skowrońska, MD principal investigator
Department of Pediatric Gastroenterology Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Children, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low rate of enrolment of patients in control group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DD frequency (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06924957, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.